Weekly Roundup – 09/03/10

The sun sets on a summer. Oil spills, floods, unemployment, record heat, election year politics bearing little, if any, substance – I say good riddance. Move on Summer of '10. Move on.

Meanwhile, there are some more interesting things in our world. Here are a few:

FDA Setting Sights on App Stores? - Reported this week by James Kendrick at jkontherun, the FDA may be looking at popular apps that provide patient support by performing monitoring functions. Ironic for an agency that for so long ignored the strategic implications of the shift in communications in the use of social media, the agency is reportedly examining the role of these apps to assess whether or not they are medical devices. Some of the apps sited in the article are those which would help patients perform monitoring functions, such as i-Phone's i-Stethoscope. The advent of social media communications and functions has been all about a shifting capacity to individuals away from institutions. Will the creators of medical apps suddenly find themselves having to file their own apps with FDA? Stay tuned.

PBS News Hour Story on FDA and Food Safety – Don't let the headline of this piece fool you. The headline "FDA's Safety Role in Question After Egg Recall" might lead one to think the piece is about whether or not the agency should be divided into a food agency and a medical product agency. At least that is what I thought it was going to be about. It wasn't. It was about funding for the agency to fulfill its mission. However, it is good viewing for three reasons. First one can see is a very effective Dr. Margaret Hamburg in action. And two, she makes an impressive case for greater funding and support for the agency. Finally, the video also addresses the enormous challenges the agency faces when inspecting the import of drugs into the U.S. – and it leaves one to wonder whether any amount of funding could possibly address the scope of the risk that is out there – a question worth pondering.

About This Blog

Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.